GB 18279.1-2015 Active National standards force_standard

GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

Publish Date: 2015-12-10 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 18279.1-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2015-12-10

Implement Date: 2017-01-01

Pages: 38 pages

Scope

This part of GB 18279 specifies the requirements for the development, validation, and routine control of the ethylene oxide sterilization process for medical devices.

Development Information

Word Count: 68 Thousand words Pages: 38 pages

Same series standard

GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1

Replace the following standards

GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization

Superseded by the following standards

GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices

Referenced Standards

GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices ISO 10012 ISO 10993-1 ISO 10993-7 ISO 11138-1:2006 ISO 11140-1 ISO 11737-1 ISO 11737-2 ISO 13485:2003 ISO 14161

Adopt standards

ISO 11135-1:2007

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05